1. Two FDA Fast Track-Designated Lung Cancer Programs
Genprex's investigational REQORSA® therapy is being developed in two FDA Fast Track-designated lung cancer treatment programs, combining it with Tagrisso® and Tecentriq®. i
Genprex, Inc. (NASDAQ: GNPX) One
Biotech
Innovator. Two Major Diseases. A New
Frontier
in Gene Therapy.
Genprex is advancing gene therapies for cancer and diabetes, with two FDA Fast Track-designated lung cancer programs combining its investigational REQORSA® therapy with Tagrisso® and Tecentriq®, alongside promising diabetes research and strategic collaborations. i
Key Highlights
2. Two Ongoing Lung Cancer Clinical Trials
Genprex is advancing its Acclaim-1 and Acclaim-3 clinical trials, evaluating REQORSA® alongside established cancer therapies to explore new treatment options for patients with lung cancer. ii
3. Advancing Gene Therapies for Cancer and Diabetes
With REQORSA® targeting lung cancer and GPX-002 showing promising preclinical results in Type 1 and Type 2 diabetes, Genprex is developing therapies for two major global healthcare challenges. iii
4. Strategic Collaborations With Leading Research Organizations
Genprex is working with Roche Diagnostics, MD Anderson Cancer Center, and Andelyn Biosciences to advance biomarker research, precision oncology, and diabetes gene therapy manufacturing. ivvvi
Investor Overview*
Genprex, Inc. (NASDAQ: GNPX) is a clinical-stage biotechnology company advancing innovative gene therapies for cancer and diabetes, two major global health challenges with significant unmet medical needs.
The company's lead oncology candidate, REQORSA®, is being evaluated in two lung cancer clinical trials, Acclaim-1 and Acclaim-3. Both programs have received FDA Fast Track Designations, reflecting the need for new treatment options. i
Beyond oncology, Genprex is developing GPX-002, a gene therapy candidate targeting Type 1 and Type 2 diabetes. Encouraging preclinical findings have demonstrated improved glucose tolerance and reduced insulin requirements in animal studies. i
Supported by collaborations with leading research institutions and biotechnology organizations, Genprex continues to advance its investigational pipeline, strengthen its technology platforms, and pursue new treatment possibilities for patients with serious diseases.
* See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.
Top Reasons to Have GNPX on Your Radar*
A Different Approach to Fighting Cancer
Genprex's REQORSA® therapy takes a differentiated approach by delivering the TUSC2 tumor suppressor gene to cancer cells. Rather than focusing on a single cancer pathway, the therapy is designed to interfere with tumor growth, activate programmed cell death, and promote immune responses against cancer. i
Early Clinical Results Show Encouraging Potential
In the Acclaim-1 Phase 1 study, three of 12 patients experienced prolonged progression-free survival after their cancer had progressed on previous treatments. One patient achieved a partial response and remained on treatment without disease progression for approximately 46 months, highlighting encouraging early findings in difficult-to-treat lung cancer. i
Targeting Multibillion-Dollar Healthcare Markets
Genprex is developing gene therapies targeting two major healthcare markets with significant unmet medical needs. The global lung cancer treatment market is projected to reach $104 billion by 2032, while diabetes accounts for approximately $1 trillion in annual global healthcare expenditures. With programs addressing both diseases, Genprex is pursuing opportunities across large and growing healthcare markets. i
Targeting a Critical Weakness in Lung Cancer
Research cited by Genprex indicates that approximately 82% of non-small cell lung cancers and 100% of small cell lung cancers have reduced TUSC2 protein expression. REQORSA® is designed to restore this important tumor suppressor function, offering a potential approach to addressing a common biological weakness in lung cancer. i
Moving Toward More Personalized Cancer Treatment
Genprex is investigating TROP2 and PTEN biomarkers that may help identify patients most likely to respond to REQORSA®. This precision medicine strategy could improve patient selection and help guide future clinical development. iv
A Growing Intellectual Property Portfolio
Genprex continues to expand patent protection for REQORSA® treatment combinations across major international markets, including the United States, Europe, and Japan. This intellectual property strategy could strengthen the company's competitive position as its investigational therapies advance. vii
Important Development Milestones Ahead
Genprex has several developments worth monitoring, including progress in its lung cancer programs, biomarker research, and preparations for future diabetes gene therapy studies. These activities could provide further insights into the company's investigational pipeline as its research and clinical programs advance. i vi
* See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.
Two Global Health Challenges. Millions of Lives at Stake. One New Frontier in Gene Therapy.
Cancer and diabetes continue to affect millions of people worldwide, creating an urgent need for better treatment options. Genprex (NASDAQ: GNPX) is developing innovative gene therapies that aim to address these diseases at their biological roots, offering a new approach to some of healthcare's biggest challenges.
Lung Cancer: Fighting a Disease That Claims Over 124,000 American Lives Every Year
With more than 2 million new cases worldwide annually and a U.S. five-year survival rate of just 28%, lung cancer remains a major global health challenge. Many patients eventually develop resistance to existing treatments, making new therapeutic approaches essential.
Genprex's investigational REQORSA® gene therapy is designed to restore the TUSC2 tumor suppressor gene in cancer cells. By targeting this underlying biological weakness, the therapy aims to disrupt tumor growth and potentially improve responses to established cancer treatments. i
Diabetes: Exploring a New Approach for 589 Million People Worldwide
Diabetes currently affects approximately 589 million adults globally, a figure projected to reach 853 million by 2050. With annual global healthcare expenditures exceeding $1 trillion, the disease places an enormous burden on patients and healthcare systems. i
Genprex's investigational GPX-002 gene therapy is designed to restore or improve the body's natural insulin-producing function. Early preclinical studies in diabetic mice and nonhuman primates have demonstrated encouraging results, including improved glucose tolerance, reduced insulin requirements, and normalized glucose levels in certain animal models. These findings support further development of a potentially disease-modifying approach for both Type 1 and Type 2 diabetes. i
The Science Behind Genprex: Reprogramming Cells. Rethinking Treatment.
Genprex (NASDAQ: GNPX) is advancing a new approach to treating serious diseases through gene therapy. Rather than focusing solely on managing symptoms, its investigational technologies aim to restore essential biological functions disrupted by cancer and diabetes. With two distinct gene therapy programs, Genprex is exploring how targeted genetic treatments could change the way these diseases are treated.
REQORSA®: Restoring the Body's Natural Defense Against Cancer
Genprex's lead oncology candidate, REQORSA®, uses its Oncoprex® non-viral gene delivery system to transport the TUSC2 tumor suppressor gene into cancer cells. TUSC2 plays an important role in controlling cell growth, activating programmed cell death, and regulating cellular functions. i
By restoring tumor-suppressor activity, REQORSA® is being investigated for its potential to interfere with cancer growth and complement existing targeted therapies and immunotherapies. Its multimodal approach offers a different way to study treatment-resistant lung cancer. i
GPX-002: Helping the Pancreas Produce Insulin Again
Genprex's investigational GPX-002 diabetes therapy takes a different approach by delivering the Pdx1 and MafA genes directly to the pancreas. In Type 1 diabetes, the therapy is designed to transform pancreatic alpha cells into insulin-producing beta-like cells. In Type 2 diabetes, it aims to rejuvenate exhausted beta cells and improve their ability to produce insulin. i
Preclinical studies have demonstrated improved glucose tolerance, reduced insulin requirements, and restoration of normal glucose levels in certain animal models, offering encouraging evidence for further research into a potentially disease-modifying treatment. i
“This research adds to our understanding of the diverse biological functions of TUSC2, the tumor suppressor gene at the center of our REQORSA oncology program. The findings highlight the important role TUSC2 plays in mitochondrial function, cellular stress responses, and protein homeostasis, while revealing intriguing differences between males and females. Importantly, the parallels identified between the preclinical findings and human brain aging data further reinforce the biological significance of TUSC2 beyond its established role in cancer. While these findings are exploratory, they contribute to a growing body of research into the broader functions of this important gene.”
— Mark Berger, MD, Chief Medical Officer, Genprex x
Clinical Progress & Early Results: Encouraging Signs in the Fight Against Lung Cancer
Genprex (NASDAQ: GNPX) is advancing its investigational REQORSA® gene therapy through clinical studies targeting two major forms of lung cancer. Early human trial results have shown encouraging signs of anti-tumor activity and prolonged disease control in selected patients, supporting continued research into new treatment options.
Acclaim-1: Promising Results in Difficult-to-Treat Lung Cancer
The Acclaim-1 trial is evaluating REQORSA® in combination with AstraZeneca's Tagrisso® for patients with advanced non-small cell lung cancer whose disease has progressed following Tagrisso-based treatment.
In the Phase 1 dose-escalation study, 3 of 12 patients experienced prolonged progression-free survival, including one patient who achieved a partial response and remained on treatment without disease progression for approximately 46 months. No dose-limiting toxicities were reported, and the study established a recommended Phase 2 dose.
The trial has advanced to its Phase 2a expansion stage to further evaluate safety, treatment response, and potential biomarkers for patient selection.
Acclaim-3: Exploring New Possibilities in Small Cell Lung Cancer
The Acclaim-3 trial is studying REQORSA® alongside Genentech's Tecentriq® as maintenance treatment for patients with extensive-stage small cell lung cancer who have not experienced disease progression following initial chemotherapy and immunotherapy.
In its Phase 1 study involving six patients, two experienced notable reductions in measurable tumor size, including one patient with a 30% reduction and another with a 23% reduction after two treatment cycles. [viii]
With Phase 1 dose escalation completed, the program has moved into Phase 2 expansion to further evaluate REQORSA's potential in this aggressive form of lung cancer.
Building on Early Clinical Evidence viii
Together, these early findings offer encouraging evidence for continued investigation of REQORSA® alongside established lung cancer treatments. Through ongoing clinical development and biomarker research, Genprex is working to better understand which patients may benefit most from its gene therapy approach.
Genprex's Gene Therapy Pipeline: Advancing Innovation Across Cancer and Diabetes
Genprex (NASDAQ: GNPX) is advancing a diverse pipeline of investigational gene therapies targeting cancer and diabetes. With REQORSA® progressing through lung cancer clinical trials and GPX-002 in preclinical development for Type 1 and Type 2 diabetes, the company continues to explore new treatment possibilities across major healthcare challenges. ix
Market Opportunity: Targeting Multibillion-Dollar Cancer & Diabetes Markets
Genprex (NASDAQ: GNPX) is developing innovative gene therapies targeting two major global healthcare markets, where growing patient populations and significant unmet medical needs continue to drive demand for advanced treatment options.
Lung Cancer: A Market Projected to Reach $104 Billion by 2032
The global lung cancer treatment market is projected to grow to $104 billion by 2032, driven by the continued need for more effective therapies. With over 2 million new lung cancer cases worldwide annually, Genprex's investigational REQORSA® therapy is being developed to address both non-small cell and small cell lung cancer, representing a potentially broad treatment opportunity. i
Diabetes: A Growing Global Healthcare Market
Diabetes affects approximately 589 million adults worldwide, with that number projected to reach 853 million by 2050. The presentation cites global Type 1 and Type 2 diabetes treatment markets of approximately $37 billion and $43 billion, respectively. Genprex's GPX-002 program is being developed for both conditions, positioning the company to explore opportunities in this large and expanding therapeutic market. i
* See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.
Recent Developments & Strategic Collaborations: Building Momentum in Gene Therapy Innovation
Genprex (NASDAQ: GNPX) continues to make progress across its oncology and diabetes programs through new research findings, strategic collaborations, and manufacturing advancements. These developments reflect the company's efforts to strengthen its science, expand its capabilities, and move investigational therapies closer to future clinical milestones.
New Research Reveals TUSC2's Potential Role in Brain Aging
October 21, 2026 — Genprex highlighted newly published peer-reviewed research examining TUSC2, the gene used in REQORSA®. The study identified its role in cellular processes associated with brain aging, offering additional scientific insights into the gene's biological significance beyond oncology. x
The study explored the biological role of TUSC2 but did not evaluate REQORSA® as a treatment for brain aging or neurodegenerative disease.
Andelyn Biosciences Selected to Scale Diabetes Gene Therapy Manufacturing
September 1, 2026 — Genprex selected Andelyn Biosciences to support manufacturing scale-up for its diabetes gene therapy program. The collaboration focuses on process optimization and clinical-grade manufacturing preparations, supporting the program's progression toward IND-enabling studies and potential future human trials. vi
Roche Diagnostics Collaboration Advances Precision Oncology
August 3, 2026 — Genprex announced a collaboration with Roche Diagnostics to validate TROP2 biomarkers that may help identify lung cancer patients most likely to benefit from REQORSA® treatment. The initiative aims to support more targeted patient selection and improve future clinical trial strategies. iv
MD Anderson Collaboration Strengthens Cancer Biomarker Research
April 21, 2026 — Genprex entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center to investigate TROP2 and PTEN biomarkers. The research may help predict patient responses to REQORSA® and support more personalized treatment strategies. v
“Selecting Andelyn marks an important step in preparing our diabetes gene therapy program for IND-enabling studies and future clinical evaluation. Andelyn's experience in AAV development and cGMP manufacturing will help us advance the manufacturing process as we work to move this program toward the clinic.”
Ryan Confer, President & CEO, Genprex vi
Upcoming Clinical & Research Milestones: Key Developments to Watch
Genprex (NASDAQ: GNPX) is working toward important milestones across its lung cancer and diabetes gene therapy programs. From anticipated clinical trial updates to biomarker research and manufacturing advancements, these developments could offer new insights into the company's investigational therapies and their future potential.
Acclaim-3: Phase 2 Interim Analysis Expected in First Half of 2027
Genprex aims to complete enrollment of the first 25 patients by the end of 2026 in the Phase 2 expansion portion of its Acclaim-3 lung cancer trial. An interim analysis is anticipated in the first half of 2027, evaluating the potential of REQORSA® combined with Tecentriq®. i
Acclaim-1: Advancing Biomarker-Guided Clinical Development
Genprex is evaluating patient samples and potential biomarkers to refine enrollment criteria for its Acclaim-1 trial. This research could help identify lung cancer patients more likely to respond to REQORSA® combined with Tagrisso®, supporting a more personalized treatment approach. i
Diabetes Gene Therapy: Moving Toward Clinical Readiness
Following its FDA meeting in the first quarter of 2026, Genprex outlined plans to optimize its Type 1 and Type 2 diabetes gene therapy constructs, advance clinical-scale manufacturing in a cGMP-compliant facility, and initiate toxicology studies. These activities are intended to support future regulatory submissions and potential clinical trials.i
Expanding Precision Medicine Research
Genprex plans to continue investigating the biology of REQORSA® and biomarkers associated with patient response. Further research could help refine clinical trial strategies, improve patient selection, and support the development of more targeted cancer therapies. i
Roche Diagnostics: Biomarker Validation Targeted for Late 2026
Genprex announced plans to complete its TROP2 biomarker assay validation studies around the end of 2026. Subject to the study results, the findings could help refine patient selection strategies for future non-small cell lung cancer clinical trials. [iv]
Company Overview
Pioneering Gene Therapies for a Healthier Tomorrow
Genprex, Inc. (NASDAQ: GNPX) is an Austin, Texas-based, clinical-stage biotechnology company focused on developing innovative gene therapies for cancer and diabetes. Founded in 2009, the company is committed to advancing new treatment approaches for patients facing serious diseases with limited therapeutic options.
At the heart of Genprex's oncology pipeline is REQORSA®, an investigational gene therapy designed to restore tumor-suppressor function in cancer cells. Using its Oncoprex® non-viral gene delivery platform, Genprex is exploring new ways to combat lung cancer and potentially enhance existing treatments.
Beyond oncology, Genprex is advancing GPX-002, an investigational gene therapy designed to restore or improve insulin-producing function in patients with Type 1 and Type 2 diabetes. Encouraging preclinical research supports the company's efforts to explore potentially disease-modifying treatments.
Through scientific innovation, strategic research collaborations, and continued clinical development, Genprex is working toward a future where gene therapy could offer new hope to patients and families worldwide.
Team
Ryan M. Confer, MS
President and Chief Executive Officer
Mark Berger, M.D.
Chief Medical Officer
Thomas Gallagher, Esq.
Senior Vice President of Intellectual Property & Licensing
David M. Schloss
Senior Vice President of Human Resources
Suzanne Thornton-Jones, Ph.D.
Senior Vice President, Regulatory Affairs and Quality
Latest News
PR NewswireGenprex Highlights New Preclinical Data Identifying Role of TUSC2, the Gene Used in REQORSA®, in Maintaining Cellular Function During Brain Aging
Read ArticlePR NewswireAndelyn Biosciences to Scale Manufacturing for Genprex’s Diabetes Gene Therapy Program
Read ArticlePR NewswireGenprex Selects Leading Clinical and Commercial Contract Development and Manufacturing Organization for Manufacturing Scale Up of Diabetes Gene Therapy
Read ArticlePR NewswireGenprex Announces Collaboration with Roche Diagnostics for Biomarker Assay Validation Studies
Read ArticlePR NewswireGenprex Receives Patent Grant from The Israel Patent Office for the Combination of Reqorsa® Gene Therapy and PD-1 Antibodies to Treat Cancer
Read ArticlePR NewswireGenprex Signs Sponsored Research Agreement to Study Biomarkers that May Predict Patient Response to Reqorsa® Gene Therapy
Read ArticleIn Summary
Genprex (NASDAQ: GNPX) is advancing gene therapies for cancer and diabetes, targeting two major healthcare challenges with innovative technologies designed to address significant unmet medical needs.
With two FDA Fast Track-designated lung cancer programs, encouraging early clinical results, and its investigational REQORSA® therapy, Genprex continues to explore new possibilities in cancer treatment.
Beyond oncology, the company's GPX-002 diabetes program has demonstrated promising preclinical findings, while collaborations with leading research institutions support further scientific and clinical development.
As Genprex progresses through clinical trials, biomarker research, and manufacturing advancements, upcoming milestones could provide valuable insights into its long-term potential. For investors following emerging biotechnology, GNPX remains a company worth watching as its gene therapy pipeline develops.
* See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.
Genprex, Inc. (NASDAQ: GNPX) — Pushing the Boundaries of Gene Therapy in Cancer and Diabetes, with Two FDA Fast Track-Designated Lung Cancer Programs, Promising Clinical Research, and Key Development Milestones Ahead
Source
i - https://www.genprex.com/wp-content/uploads/2026/07/Genprex_Master_July-2026_email-version.pdf
ii - https://www.genprex.com/programs/
iii - https://finance.yahoo.com/news/genprex-announces-positive-preliminary-preclinical-120000519.html
vii - https://finance.yahoo.com/news/genprex-strengthens-intellectual-property-portfolio-130000683.html
viii - https://www.genprex.com/programs/
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(Last updated: October 28, 2026 @ 9:15 AM)